Millennium Users Manual Rev 7

EC DECLARATION OF CONFORMITY Sechrist Industries, Inc. 4225 E. La Palma Anaheim, CA 92807 Declares that the medical device described hereafter: Model: Millennium Infant Ventilator is in conformity with the essential requirements and provisions of Council Directive 93/42/EEC, Annex II. Conformity has been achieved under the supervision of Notified Body Number 0120, SGS Yarsley Certification Services Ltd, Unit 202B Worle Parkway, Weston super Mare, North Sommerset BS22 0WA, United Kingdom.

__________________ Greg Godfrey Vice President Quality Assurance & Regulatory Affairs

______________

0120 93/42/EEC 4225 E La Palma Avenue Anaheim California 92807 Telephone 714 / 579-8400 Fax 714 / 579-8424 Website www.sechristUSA.com

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TABLE OF CONTENTS EC DECLARATION OF CONFORMITY ... 2 INTRODUCTION ... 4 OWNER / USER RESPONSIBILITY ... 4 INDICATIONS FOR USE ... 4 CONTRAINDICATIONS ... 6 SYMBOLS... 7 WARNINGS ... 9 WARRANTY ... 16 SPECIFICATIONS ... 17 GENERAL DESCRIPTION ... 20 STANDARD COMPONENTS ... 21 ASSEMBLY / SET-UP ... 21 OPTIONAL BATTERY BACK-UP... 24 SUPPLEMENTAL EQUIPMENT ... 29 PERFORMANCE VERIFICATION ... 31 CONTROLS ... 38 DISPLAYS ... 43 MODES OF OPERATION ... 44 ALARMS ... 57 ROUTINE MAINTENANCE... 67 6 month MAINTENANCE PROCEDURE ... 73 2 year MAINTENANCE ... 74 TROUBLESHOOTING ... 75 SERVICE POLICY ... 76 APPENDIX A Millennium Assembly ... 77 APPENDIX B Infant Exhalation Block Assembly ... 78 APPENDIX C Pediatric Exhalation Block Assembly ... 79 APPENDIX D Infant Breathing Circuit with Block Assembly ... 80 APPENDIX E Pediatric Breathing Circuit with Block Assembly ... 81 INDEX ... 82 3

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INTRODUCTION We at Sechrist Industries, Inc. thank you for choosing the Sechrist Millennium ventilator. We also caution you that before attempting to use the ventilator in a patient care setting, the operator must be thoroughly familiar with the instructions in this manual and any product labeling. Throughout this manual, warnings, cautions, and notes will be utilized to bring attention to particularly important matters. WARNINGS indicate the possibility of personal injury or death to the patient and/or operator of the device if the warning is ignored. CAUTIONS indicate the potential of damage to equipment and/or other property if the caution is ignored. NOTES indicate a call to attention to statements that are intended to supplement or emphasize basic instructions contained within this manual.

OWNER / USER RESPONSIBILITY If utilized and maintained properly, the Sechrist Millennium ventilator will perform in conformance with the specifications and descriptions contained within this manual and accompanying labeling. Do not attempt to operate this equipment without first thoroughly understanding the contents of this manual and any accompanying product labeling. The Sechrist Millennium should be periodically verified for functionality as outlined in this manual. A malfunctioning device should never be used in a clinical setting. All servicing of this ventilator must be accomplished by a Sechrist trained and authorized individual and must only involve parts designated by Sechrist Industries.

INDICATIONS FOR USE By definition, acute respiratory/ventilatory failure is the indication for mechanical ventilatory support 1. The Sechrist Millennium ventilator is intended to provide ventilatory support for the neonatal, infant or pediatric patient requiring mechanical ventilation. Many disorders or a combination of disorders may result in acute or impending ventilatory failure. Mechanical ventilatory support may be indicated due to existing or impending ventilatory failure as often occurs in the following disorders2.

1 The C.V. Mosby Company, Eagan’s Fundamental’s Of Respiratory Care, 1990 2 W.B. Saunders Company, Care Of The High-Risk Neonate, 1979

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Pulmonary Respiratory distress syndrome (RDS) Aspiration pneumonia Pneumonia Pulmonary hemorrhage Pulmonary edema Wilson-Mikity syndrome Bronchopulmonary dysplasia Pulmonary insufficiency or prematurity Loss of lung volume Pneumothorax Tumor Diaphragmatic hernia Airway Choanal atresia Pierre-Robin Micrognathia Nasopharyngeal tumor Abnormalities of muscles of respiration Phrenic nerve palsy Spinal cord injury Myasthenia gravis Central problems Apnea of prematurity Drugs; morphine, magnesium, mepivacaine Seizures Birth asphyxia Hypoxic encephalopathy CNS hemorrhage Ondine’s curse Miscellaneous Patent ductus arteriosus with congestive heart failure Post-operative Asphyxia neonatorum Tetanus neonatorum Extreme prematurity Shock Sepsis

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CONTRAINDICATIONS Mechanical ventilatory support may not be warranted when there is no reasonable chance of intact survival as in the following conditions;3 Anencephaly Trisomy 13-15 or 16-18 Werdnig-Hoffmann paralysis Potter’s syndrome Intracranial hemorrhage with cerebral involvement Hypoxic encephalopathy with absent reflexes or absent cerebral blood flow

3 W.B. Saunders Company, Care Of The High-Risk Neonate, 1979

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SYMBOLS The following symbols appear on the Millennium Infant Ventilator

Symbol

WARNING

~

Reference

IEC 60878 Symbol #03-02

This symbol indicates ATTENTION, consult the accompanying documents.

IEC 60417-1 Symbol #5009

This symbol indicates the ON and OFF condition for the part of the equipment

IEC 60417-1 Symbol #5021

This symbol indicates the POTENTIAL EQUILIZATON CONNECTOR used to connect the equipment to an electrical installation earth busbar.

IEC 60878-02 Symbol #02

This symbol indicates TYPE B applied part, which indicates equipment that provides a particular degree of protection against electrical shock, particularly with regards to allowable leakage current and of the protective earth connection.

IEC 60417-1 Symbol #5032

This symbol is located on the power supply. It indicates the equipment is SUITABLE FOR ALTERNATING CURRENT.

IEC 60417-1 Symbol #5031

This symbol indicates DC POWER CONNECTION.

IEC 60417-1 Symbol #5035

This symbol indicates an OUTPUT.

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Meaning

P/N 100236 Rev. 7

Symbol

Reference

Meaning

IEC 60417-1 Symbol #5034

This symbol indicates an INPUT.

IEC 60417-1 Symbol #5013

This symbol indicates the ALARM SILENCE key. (Silences alarm for 114 seconds (+ 5 seconds).

IEC 60417-1 Symbol #5056

This symbol indicates BRIGHTNESS ADJUSTMENT.

IEC 60417-1 Symbol #5057

This symbol indicates CONTRAST ADJUSTMENT.

This symbol indicates EUROPEAN CONFORMITY, to the European Medical Device Directive MDD 93/42/EEC and IEC 60601-1 and 60601-2-12.

This symbol indicates CANADIAN STANDARDS ASSOCIATION approval to CSA C22.2 No. 601.1, CSA C22.2 No. 601.2-12 and UL 2601

C

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WARNINGS

WARNING

WARNING Do not attempt to operate this ventilator before thoroughly reading and understanding the descriptions and instructions contained within this document.

WARNING Federal law restricts this device to sale by or on the order of a physician. The Sechrist Millennium is a sophisticated instrument designed for use by qualified personnel under the direction of a qualified physician.

WARNING The Sechrist Millennium should be maintained and serviced only by Sechrist Industries factory-trained personnel or by written instructions directly from Sechrist Industries.

WARNING A defective or malfunctioning ventilator must never be placed into clinical service.

WARNING The Sechrist Millennium will not be fully operational without the use of the SmartSync Patient Sensing Device.

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WARNING The SmartSync patient sensing device is intended FOR SINGLE PATIENT USE ONLY.

WARNING The Sechrist Millennium must be serviced and repaired only in accordance with the policies and instructions of Sechrist Industries. This product must not be modified in any fashion without written authorization from Sechrist Industries.

WARNING The user of the Sechrist Millennium shall have sole responsibility for any malfunction, which results from improper usage, faulty maintenance, improper and/or unauthorized repairs, damage or alteration performed by anyone other than Sechrist Industries.

WARNING Constant attendance by qualified personnel is required whenever this device is in clinical use. The use of this life support system, which incorporates built-in alarm systems, does not provide absolute assurance of warning for every type of malfunction or concern that may occur.

WARNING If the Sechrist Millennium fails to perform as described, remove the unit from service and refer it to a Sechrist authorized service technician. The unit should not be utilized until proper performance has been verified.

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WARNING The internal air-oxygen mixer is designed for use with medical air and oxygen only. Do not modify these inlets for use with other breathing or anesthetic gases.

WARNING DANGER: Explosion hazard. Do not use in the presence of flammable anesthetics.

WARNING Only parts approved by Sechrist Industries and provided by authorized distributors or Sechrist Industries are to be used as replacements.

WARNING Maintain inlet pressures within a differential of 20 psig (138 kPa) to ensure proper operation.

WARNING An independent device for manual ventilation must always be available when the Sechrist Millennium is in clinical use.

WARNING Never use the Sechrist Millennium ventilator without the safety pressure relief valve installed and appropriately adjusted. Verify that the exposed valve stem operates freely and is not obstructed in any manner. Do not tape or occlude the vent holes in the valve body or the valve will become inoperative.

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WARNING Always monitor oxygen concentrations with a calibrated oxygen analyzer equipped with high and low alarms to ensure that the desired oxygen concentration is being delivered to the patient. Oxygen concentrations must be analyzed at or near the patient airway.

WARNING - EXPLOSION HAZARD Oxygen vigorously accelerates combustion; do not use any instruments or equipment that may have been exposed to oil or grease contamination.

WARNING Liquid water in the compressed air supply can cause malfunction of this equipment. Use specified filter / water trap assembly.

WARNING Do not occlude or obstruct the orifices on the bottom of the exhalation block assembly. Obstruction of these ports will result in ventilator malfunction

WARNING The exhalation diaphragm, p/n IV 305-05, is a single use component. It should be discarded and replaced between patient use.

WARNING Do not attempt to use an A.C. power adapter other than the configuration provided with this ventilator.

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WARNING: ELECTRICAL SHOCK HAZARD This equipment must be properly grounded. The provided grounding stud shall be separately connected to the protective earth ground if required.

WARNING Fire may result if incorrect fuses are used. Replace fuses as marked.

WARNING The optional battery contains toxic materials. Avoid shorting. Use approved charging methods.

WARNING The batteries in the battery compartment are Nickel Metal Hydride (NiMH) type. Recycle or dispose of batteries properly.

WARNING Do not disconnect the DC power cord from the Backup Battery while the product is in operation. Always turn the Battery Power N/OFF switch to OFF when the unit is not in use

WARNING Battery operating life may be affected by battery age and the number of times it has been discharged and recharged. Over time the battery will degenerate and will not provide the same amount of operating time per charge that is available from a fully charged new battery. Only use Sechrist p/n 39064.

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WARNING Disposal of batteries in fire or disposal or use with other battery types, may result in expolosion or lead to and cause personal injury.

WARNING All alarms must be properly set when using the Sechrist Millennium. WARNING The Sechrist Millennium  is not recommended for use as a transport ventilator.

CAUTION Routine maintenance procedures contained within this manual may involve opening the ventilator enclosure, which constitutes an ELECTRICAL SHOCK HAZARD. Qualified service personnel must perform these procedures.

CAUTION Battery may explode or leak and cause burn injury if disposed of in fire, mixed with a different battery type, inserted backwards, or disassembled.

CAUTION The Backup Battery is designed to be charged by the Millennium infant ventilator only. Under no circumstances should an attempt be made to charge it in any other way.

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CAUTION The auxiliary flow meter outlet is an unregulated gas source with no relief valve.

CAUTION Electrically conductive hoses and/or tubing must not be used in conjunction with this device. NOTE: •

Activation of the high inspiratory pressure alarm will result in the following conditions; •

Pressure within the patient circuit will be vented to ambient.

•

Inspiratory and expiratory pressure controls will become temporarily inoperative.

•

The flow meter is not back-pressure compensated.

•

Follow institutional infection control guidelines when replacing inspiratory bacteria filter.

•

Disinfect/sterilize contaminated parts as defined in the routine maintenance section of this manual.

•

The Millennium infant ventilator should only be connected to appropriate medical grade gas sources capable of delivering a regulated 30 to 60 PSIG (207-414 kPa) at 40 LPM.

•

The Millennium infant ventilator is shipped with appropriate gas fittings and hoses for the intended environment, i.e., DISS (U.S.A., Canada, Germany), NIST (U.K.), Air Liquide (France), SIS (Australia).

•

The Millennium infant ventilator complies with the requirements of IEC 606011-2 (EMC collateral standard), including the E-field susceptibility requirements of 10 volts per meter. However, even at this level of immunity, certain transmitting devices (cellular phones, walkie-talkies, etc.) emit radio frequencies that could disrupt ventilator operation if operated in a range too close to the ventilator.

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WARRANTY Sechrist Industries warrants this product to meet the published specifications and to be free from defects in material and workmanship under normal use for a period of one (1) year from the date of purchase. THE FOREGOING IS IN LIEU OF ANY OTHER WARRANTY, EXPRESSED, IMPLIED, OR STATUTORY, INCLUDING, WITH OUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY. The sole liability of Sechrist Industries, under this warranty is limited to replacing or repairing, at the discretion of Sechrist Industries, equipment or parts which fail to meet the published specifications or which become defective during the warranty period and which, upon examination by Sechrist Industries are found not to meet the published specifications or to be defective in material or workmanship. Sechrist Industries will not be liable under this warranty unless the following provisions are strictly complied with: (a) Sechrist Industries is promptly notified, in writing, upon discovery of the failure of said product or equipment to meet the published specifications, or of defects in material or workmanship, (b) that examination by Sechrist Industries of said product, equipment, or part shall disclose to Sechrist Industries satisfaction that such defect has not been caused by improper usage, accident, neglect, alteration, abuse, improper installation, or unauthorized repair. Products, equipment, or parts replaced under this warranty are warranted only through the terms of the original warranty. Sechrist Industries neither assumes nor authorizes any other person or entity to assume for it any other warranty, obligation, or liability I connection with its products or equipment whatsoever, and this warranty can only be changed by a duly authorized representative of Sechrist Industries. Sechrist Industries makes no representations or warranties whatsoever as to the fitness or usefulness of the products or equipment manufactured by it for any medical treatment or physical condition whatsoever. In no event shall Sechrist Industries be liable for any special or consequential damages, or loss of uses of the machine, or loss of time, inconvenience, or any delay in the performance of this warranty. Any authorization for repair or alteration by the buyer must be in writing from Sechrist Industries to prevent the voiding of this warranty.

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SPECIFICATIONS Recommended Applications:

Neonatal, infant & pediatric patients < 50 Kg

Flow:

2-32 lpm; flush 40 lpm

FIO2

.21 to 1.0

Modes of operation:

Assist/Control (A/C), Intermittent Mandatory Ventilation (IMV), Synchronized Intermittent Mandatory Ventilation (SIMV), Continuous Positive Airway Pressure (CPAP) + backup ventilation, and Standby

Inspiratory Time:

0.1 to 3.0 seconds

I:E Ratio:

Normal Range: 1:1.0 to 1:10 (with Sensitivity @ OFF) 1:1.0 to 1:99 (with Sensitivity set) Inverse Range: 1.0:1 to 4.0:1

Rate:

2 to 150 breaths per minute

Expiratory Pressure:

0 to 20 cmH2O (0 to 2 kPa)

Inspiratory Pressure:

5 to 70 cmH2O (0.5 to 7 kPa)

Manual Breath:

Electronically controlled, based upon the inspiratory pressure, inspiratory time, FIO2, flow and waveform control settings

Waveform:

Adjustable from square to tapered.

Alarms:

High Inspiratory Pressure Low/Prolonged Inspiratory Pressure Low PEEP/Baseline Pressure Apnea/Circuit Disconnect Sense Line Disconnect High Respiratory Rate Loss/Low Electrical Power 17

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System Error/Vent Inop Low/Loss of Inlet Gas Internal Battery Power Prolonged Inspiratory Time Standby-Too-Long

Alarm Delay:

3 to 15 seconds

Alarm Mute:

114 seconds (+ 5 seconds)

Safety Pressure Relief Valve:

15 to 85 cmH2O (1.5 to 8.5 kPa) (factory set at 25 cmH2O +5 cmH2O)

Displays/Indicators:

DC Power Battery Power Alarm Alarm Mute Mode Message Peak Pressure PEEP/Baseline Pressure Calculated I:E Ratio / Inverse Status Mean Airway Pressure Proximal Airway Pressure Bar Graph Measured Respiratory Rate Set Respiratory Rate Set Inspiratory Time 18

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Dimensions:

13.5 H x 11W x 9.5D (in) 34.3H x 27.9W x 24.1D (cm)

Weight:

21 lbs. (9.5Kg)

Gas Consumption:

14 lpm above the continuous flow setting

Power Requirements:

AC Power Requirements: Voltage: 100-250 VAC, Frequency: 50-60 Hz, Current: 0.85 Amps.

DC Power Protection:

1 amp time delay fuse

Battery Backup (optional p/n 21513)

Provides a minimum of 2 hours of backup power

Data Transmission

Fiberoptic link

SmartSync Pressure Sensor

Maximum sensitivity: – 0.10 cm H2O Deadspace:

1.5 cc

Weight:

5 grams

Environmental Conditions: Normal Operation: +50 °F to +100 °F, 0 to 90% Relative Humidity, Noncondensing, at 8,000 ft maximum. Storage and Transportation: +40 °F to +120 °F, 0 to 90% Relative Humidity, Noncondensing, at 40,000 ft. maximum.

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GENERAL DESCRIPTION The Sechrist Millennium Infant/Pediatric ventilator is a sophisticated device designed for use by qualified and properly trained personnel. It is restricted to use by or upon the direction of a qualified physician. Before attempting to use this instrument in a patient care setting, operating personnel must become competent in the use of this device. The Sechrist Millennium is a continuous flow, time-cycled, pressure limited ventilator. The basic principle of the ventilator operation is as follows. Air and oxygen are supplied to the gas mixer where desired oxygen concentrations are established. A continuous gas flow rate is selected by the Flow control and indicated by the Flow meter. Gas flow is then directed from the flow meter through the patient circuit and generally through a humidification device (not included) where gas is warmed and humidified for delivery to the patient. At the patient connection, assisted and synchronized ventilation is accomplished by use of the SmartSync sensor, a patentpending sensor of patient effort that also provides for monitoring and display of certain settings or measurements. Gas then travels past the patient connection and to ambient through the exhalation valve assembly. Lung inflation occurs with the closing of the exhalation valve thereby creating a pressure increase in the patient circuit. The exhalation valve serves as the principle component controlling pressures within the patient circuit. Ventilator controls allow the operator to determine the pressure of the gas signal applied to the diaphragm in the exhalation valve throughout the breath cycle, thereby establishing the inspiratory and expiratory pressures. The inspiratory pressure control establishes the setting of the peak inspiratory pressure during the inspiratory phase and the expiratory pressure control determines the expiratory pressure setting during the expiratory phase of ventilation. A microprocessor-controlled system allows the user to select the inspiratory time and respiratory rate. From these control settings, expiratory time and I:E ratio are calculated, and I:E ratio is displayed on a continuous basis. Manual breaths can be delivered by the clinician and are based upon the settings of Inspiratory pressure, Inspiratory time, FIO2, Flow and Waveform controls Multiple manual breaths can be delivered by repeated depression of the Manual Breath button.

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